AlopeciaNCT06497764
Evaluating Vibrational Anesthesia in Scalp Platelet Rich Plasma (PRP)
A study testing Vibrational Anesthesia (VA) Device and PRP Treatment in people with Alopecia, run by NYU Langone Health at 1 site in United States.
Trial summary
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Alopecia
- What is being tested?
- Vibrational Anesthesia (VA) Device and PRP Treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2025to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
- Able to participate in study procedures.
- Able to provide consent.
Who cannot join
- Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
- Patients unable to consent.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot, Randomized, Non-blinded, Single-center Study of the Efficacy of a Vibrational Anesthesia (VA) Device on Reducing Pain During Platelet Rich Plasma (PRP) Scalp Treatment for Alopecia
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.
- Conditions
- Alopecia
- Being tested
- Vibrational Anesthesia (VA) Device, PRP Treatment
- Medical subject headings
- Alopecia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrational Anesthesia (VA) DeviceDevice
Also called Buzzy bee-striped personal
The half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain.
PRP TreatmentProcedure or surgery
PRP (a needle-related procedure) will be delivered per routine standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Control (PRP Alone), then Intervention (PRP with VA) | Experimental | Participants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment. Receives: Device: Vibrational Anesthesia (VA) Device; Procedure: PRP Treatment |
| Intervention (PRP with VA), then Control (PRP Alone) | Experimental | Participants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone. Receives: Device: Vibrational Anesthesia (VA) Device; Procedure: PRP Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels.
Measured: End of procedure (About 10 minutes, Day 1)
Secondary outcomes (1)
Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2024
- Study startApr 2025 (estimated)
- Primary completion1 Jul 2025 (estimated)
- Study completion1 Jul 2025 (estimated)
Why it stopped: Departmental research administration decided to close the study as there had been no enrollment. No participants were screened or consented.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AlopeciaStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristen Lo Sicco, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06497764
- Sponsor's protocol ID
- 24-00472
- Status last verified
- Jan 2026
- First submitted
- 5 Jul 2024
- Last updated
- 29 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Kristen Lo Sicco. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot, Randomized, Non-blinded, Single-center Study of the Efficacy of a Vibrational Anesthesia (VA) Device on Reducing Pain During Platelet Rich Plasma (PRP) Scalp Treatment for Alopecia
- ClinicalTrials.gov ID
- NCT06497764
- Acronym / sponsor ID
- 24-00472
- Conditions
- Alopecia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Departmental research administration decided to close the study as there had been no enrollment. No participants were screened or consented.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- Apr 2025 (estimated)
- Primary completion
- 1 Jul 2025 (estimated)
- Study completion
- 1 Jul 2025 (estimated)
- First posted
- 12 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is prospective, single-site, randomized split-scalp pilot and survey study of patients at the NYU Skin and Cancer Clinic or the Faculty Group Practice. The investigators will randomize half of the scalp of each patient: one half will receive vibrational anesthesia (VA) via a device and the other half will not. Approximately 100 unique patients will be recruited (there will only be one study group). During the standard of care platelet rich plasma (PRP) procedure, a REDCap survey questionnaire will be provided asking the patients to rate their pain with the visual analogue scale (VAS). A simple paired t-test will be used to test significant improvement in pain scores between the two halves of the scalp.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control (PRP Alone), then Intervention (PRP with VA) | Experimental | Device: Vibrational Anesthesia (VA) Device, Procedure: PRP TreatmentParticipants in this study arm will receive treatment with PRP alone first, then PRP+VA second. The first half of the scalp of each patient will be randomized to receive standard-of-care PRP alone. The second half of the scalp of each patient will receive VA via a device during the standard-of-care PRP treatment. |
| Intervention (PRP with VA), then Control (PRP Alone) | Experimental | Device: Vibrational Anesthesia (VA) Device, Procedure: PRP TreatmentParticipants in this study arm will receive treatment with PRP+VA first, then PRP alone second. The first half of the scalp of each patient will be randomized to receive VA via a device during the standard-of-care PRP treatment.. The second half of the scalp of each patient will receive standard-of-care PRP treatment alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients must have received at least one treatment of PRP to the scalp, which may include the PRP procedure performed day of.
- Able to participate in study procedures.
- Able to provide consent.
Key exclusion criteria (2 listed)
- Patients missing the following data will be excluded from the final analysis: Patient age, gender, type of alopecia, PRP documentation.
- Patients unable to consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrational Anesthesia (VA) DeviceAlso: Buzzy bee-striped personalThe half of the patient's scalp randomized to receive VA during PRP treatment will receive VA via the Buzzy bee-striped personal. The device is powered by two AAA batteries and is indicated for use for pain reduction. It uses the Melzack and Wall's Gait Control theory, which states that activation of non-nociceptive fibers can interfere with signals from pain fibers to inhibit overall sensation of pain. | Device | Control (PRP Alone), then Intervention (PRP with VA), Intervention (PRP with VA), then Control (PRP Alone) |
| PRP TreatmentPRP (a needle-related procedure) will be delivered per routine standard of care. | Procedure or surgery | Control (PRP Alone), then Intervention (PRP with VA), Intervention (PRP with VA), then Control (PRP Alone) |
Primary outcome
Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure
Time frame: End of procedure (About 10 minutes, Day 1)
At the end of the 10-minute PRP procedure, participants will rate their pain on: 1) The side of the scalp with no VA, and 2) the side of the scalp with VA. Participants will rate pain using a VAS, where pain is rated on a 0-10 scale; larger values indicate greater pain levels.
1 secondary outcome
Percentage of Participants who Opt to use VA among Participants in the "Control, then Intervention" Arm
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2026.
- Individual participant dataSharing planned: Yes. The de-identified participant data from the final research dataset used in the published manuscript will be shared upon reasonable request beginning 9 months and ending 36 months following article publication or as required by a condition of awards and agreements supporting the research provided the investigator who proposes to use the data executes a data use agreement with NYU Langone Health. Requests may be directed to Dr. Kristen Lo Sicco. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristen Lo Sicco principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrational Anesthesia (VA) Device and PRP Treatment in people with Alopecia, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (VAS) Rating of Pain Perception at End of Procedure (time frame: End of procedure (About 10 minutes, Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2026.